Stability of Injectable Oxytocics in Tropical Climates: Results of Field Surveys and Simulation Studies on Ergometrine, Methylergometrine and Oxytocin - EDM Research Series No. 008: Materials and methods: Sampling methods

Stability of Injectable Oxytocics in Tropical Climates: Results of Field Surveys and Simulation Studies on Ergometrine, Methylergometrine and Oxytocin - EDM Research Series No. 008
(1993; 50 pages)

Índice de contenido

Summary
Introduction
	Outline of the study
	Acknowledgments
Materials and methods
	Sampling methods
	Temperature and light conditions, time interval
	Laboratory analysis
Results
	Field research
	Simulation study
Discussion
	Field research
	Pattern of stability of common injectable oxytocics
		Ergometrine
		Methylergometrine
		Oxytocin
		Influence of light
		Short exposure to high temperature
		Hypothetical loss of active ingredient in tropical climates
	Selection of the most Stable injectable oxytocic
	Relation between colour and level of (methyl)ergometrine
	Oxygen content and pH
Conclusions and recommendations
References
Annexes
	Annex 1: Results of field studies on ergometrine injection
	Annex 2: Results of field studies on oxytocin injection
	Annex 3: Results of simulation studies
	Annex 4: Summary results of simulation studies
	Annex 5: Stability of (methyl) ergometrine injection (dark versus light)
	Annex 6: Comparison ergometrine vs. methylergometrine injection (2 brands each)

Sampling methods

Field research

Seven samples of ergometrine maleate injection were taken from current stock in Central Medical Stores in Banjul (Gambia), Khartoum (Sudan) and Harare (Zimbabwe), 22 samples were taken from 13 different district hospitals in Malawi, Sudan and Zimbabwe. The 29 samples were produced by 10 different manufacturers from 6 countries; 25 samples were imported. Full details of all samples are given in Annex 1. Six samples of oxytocin injection, all imported from the same manufacturer, were taken from five district hospitals in Zimbabwe.

Simulation study

Two batches each of three brands of ergometrine maleate injection were included in the simulation study. This selection covers all major suppliers of UNICEF and IDA. In addition, two batches of specially produced ergometrine maleate injection were included for a controlled comparison of their stability with similar solutions of methylergometrine injection, A total of 392 samples were analyzed. Two batches each of three brands of methylergometrine maleate injection, representing the major suppliers to UNICEF and IDA, were included plus two batches specially produced for a controlled comparison with ergometrine. A total of 392 samples were analyzed. Two batches each of three brands of oxytocin injection, representing the major suppliers of UNICEF and IDA, were included in the study, A total of 180 samples were analyzed.